Study of Acid Reflux in Asthma

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The planned enrollment was for 400 participants, 403 participants actually were enrolled and randomized in the trial. It is not uncommon for clinical trials not to exactly meet the sample size stated in the protocol.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Placebo

40 mg of placebo twice daily

Esomeprazole

40 mg of esomeprazole twice daily

Participant Flow: Overall Study

Placebo

Esomeprazole

STARTED

199 [1]

203 [1]

COMPLETED

193

200

NOT COMPLETED

6

3

Did not have follow-up diary cards

6

3

[1]

The design was for 200 participants per group, the study did not exactly meet the design.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Placebo

40 mg of placebo twice daily

Esomeprazole

40 mg of esomeprazole twice daily

Total

Total of all reporting groups

Baseline Measures

Placebo

Esomeprazole

Total

Overall Participants Analyzed [Units: Participants]

199

203

402

Age [Units: Years]Mean (Standard Deviation)

42 (13)

42 (13)

42 (13)

Gender [Units: Participants]

Female

143

130

273

Male

56

73

129

Race/Ethnicity, Customized [1] [Units: Participants]

White

103

102

205

Black

73

79

152

Hispanic

17

18

35

Other

6

4

10

[1]

Race or ethnic group was self-reported.

Asthma medication use [Units: Participants]

Inhaled corticosteroids

50

44

94

Combination of fluticasone and salmeterol

149

159

308

Body-mass index >=30 [1] [Units: Participants]

BMI >=30

107

102

209

BMI <30

92

101

193

[1]

The body-mass index is the weight in kilograms divided by the square of the height in meters.

Conditions other than asthma [1] [Units: Participants]

Gastroesophageal reflux disease

38

21

59

No GER reported

161

182

343

[1]

These conditions were self-reported.

Former smoker [Units: Participants]

Former Smoker

40

31

71

Never smoked

159

172

331

Health Care Visits [1] [Units: Participants]

Health care visit for asthma exacerbation

126

109

235

No visit

73

94

167

[1]

Unscheduled health care visit for asthma in previous year

Pulmonary function [Units: Participants]

Participants with 20% post-diluent measurement

92

83

175

20% from post-diluent contraindicated

102

117

219

Missing

5

3

8

potential Hydrogen (pH) monitoring [1] [Units: Participants]

Positive result

62

61

123

Negative result

89

92

181

Missing result

48

50

98

[1]

Results of ambulatory measure of esophageal potential Hydrogen (pH) for 16 to 24 hours. Test were considered positive if pH was less than 4 for more than 5.8% of the total tiem, 8.2% of upright time, or 3.5% of supine time.

%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator [1] [Units: Percent]Mean (Standard Deviation)

78 (15)

76 (16)

77 (16)

[1]

Percent of the predicted value for the amount of air expired in the first second during a forced expiratory maneuver (FEV1) based on gender, age and ethnicity that the measured value is.

Age of onset of asthma [Units: Years]Mean (Standard Deviation)

17 (17)

17 (16)

17 (16)

Age of participants [Units: Years]Mean (Standard Deviation)

at randomization

42 (13)

42 (13)

42 (13)

at onset of asthma

17 (17)

17 (16)

17 (16)

Asthma scores [1] [Units: Score]Mean (Standard Deviation)

ACQ

1.9 (0.8)

1.8 (0.8)

1.8 (0.8)

ASUI

0.74 (0.18)

0.76 (0.15)

0.75 (0.15)

mini asthma quality of life questionnaire

4.7 (1.2)

4.7 (1.2)

4.7 (1.2)

[1]

Asthma Control Score (ACS)ranges from 0 to 6, lower scores indicating better asthma control and 0.5 as the minimal clinically important difference; Asthma Symptom Utility Index (ASUI) score ranges from 0 to 1, higher scores indicating less severe asthma; Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) score range from 1 to 7, higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.

Mean Change in the dose of methacholine that results in a 20% drop in FEV1

Time Frame

Baseline to 24 Weeks

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.